You are on page 1of 16

JOMI on CD-ROM, 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E…

Copyrights © 1997 Quinte…

Craniofacial Osseointegration: The Canadian Experience
John F. Wolfaardt, BDS, MDent, PhD/Gordon H. Wilkes, MD, FRCS(C)/Stephen M. Parel, DDS/Anders Tjellström, MD, PhD

A survey was undertaken to determine the number of centers in Canada with an active involvement in extraoral osseointegration. It was found that six centers had placed 222 implants in 91 patients in Canada. The individual implant success rates for the Canadian experience were compared with the published Swedish and United States' experience. The Canadian experience is combined with the Swedish and United States' experience to provide retrospective multinational multicenter data. The data given should be viewed as providing trends only and not as definitive expectations of predictable success rates. The success rates are considered likely to change with time as the number of patients treated increases and the duration of follow-up is extended. The mastoid region in nonradiated patients is considered to provide a high degree of predictable individual implant success. The success rates in radiated patients yield far lower success rates, which vary with anatomic location. The criteria for success in using craniofacial implants need to be defined and should reflect the differences between extraoral and intraoral implants. (INT J ORAL M AXILLOFAC IMPLANTS 1993;8:197—204.)
Key words: craniofacial implants, criteria for success, extraoral implants, multicenter study, multinational study, radiation therapy

Factors influencing the success or failure of a facial prosthesis are numerous. For a
facial prosthesis to be successful it must meet criteria of esthetic acceptability, functional performance, biocompatibility, and desired retention.1 Providing adequate retention has been a constant challenge with many facial prostheses. Inherent mechanical retention within the defect or the use of adhesive systems have frequently proven to be problematic or unacceptable.2-10 With the introduction of osseointegration to the extraoral craniofacial complex, predictable mechanical retention of facial prostheses was established. In addition to providing predictable retention, several other important advantages have been achieved. Esthetics and durability of prostheses have been enhanced because fine feathered margins are maintainable and not liable to damage by adhesives and solvents. Skin and mucosal surfaces are subject to less mechanical and chemical insult from intrinsic mechanical retention, adhesives, and adhesive solvents. Clinical experience has shown that craniofacial osseointegration changes the patient's perceptions of a facial prosthesis ( Figs 1 to 4). The prosthesis is no longer seen as a foreign object about the head and

11 The application of craniofacial osseointegration biotechnology to facial reconstruction was first reported in 1977. In some anatomic locations. the first implants were placed to retain an auricular prosthesis. These authors investigated the number of implants placed into patients who had and had not received radiotherapy.1%. the patient appears to recognize the prosthesis as self. With the implant-supported and -retained prosthesis. In 1991. Materials and Methods All centers in Canada likely to be involved with craniofacial osseointegration were .6 In 1979. and once osseointegration has been established a hearing aid can be attached to provide bone conduction hearing (Figs 5 to 7).9%. These workers concluded that the irradiated patient should be approached with care and in an environment that fully appreciated the risks associated with external beam therapy. A further extension of this biotechnology has been to use the implants to retain hearing aids. the biotechnology was released internationally with the introduction of training courses in Göteborg. when an implant fixture was placed into the cranial skeleton to retain a bone-anchored hearing aid. Several facts emerging from Parel and Tjellström's study are important. The results gathered in the present survey are added to those of the Swedish and United States report to provide broader multinational data.JOMI on CD-ROM. Sweden. The combined center individual implant success rate for radiated patients was 61. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… neck. Parel and Tjellström11 presented the results of the Swedish and United States' experience with extraoral osseointegration. The present report provides a survey of the Canadian experience with craniofacial osseointegration. Orbital implants in this category of patients provides an equally impressive combined success rate of 93. Craniofacial osseointegration biotechnology provides patients with congenital or acquired deformities an opportunity to be treated conveniently and with a predictable retention base for a variety of prosthetic devices. An implant is placed into the mastoid region. The results of the Swedish and United States centers have been combined (Tables 1 to 3). Parel and Tjellström found in this early evaluation that the nonradiated patient could be effectively treated with osseointegrated implants to retain a facial prosthesis in various areas of the facial skeleton. Success rates in the midface and in radiated patients proved more variable. While no experience with bone-anchored hearing aids was reported from the United States. In May 1984. The study indicates that implant placement in the mastoid region carries a high success rate based on individual implant stability with a combined center success rate of 98. Swedish and United States' Experience A study of experience with craniofacial implants was conducted by Parel and Tjellström11 and involved the work of 1 Swedish and 13 United States centers.3% in nonradiated patients. the number of patients treated was too small to draw firm conclusions. the Swedish experience was included.

00-mm and 4. The following information for radiated and nonradiated patients was requested: number of implants placed. Implants placed in the mastoid region for attachment of bone-anchored hearing aids were included in a separate category.000 to 7. . It was found that 41 patients had been treated with extraoral implants to retain facial prostheses. Bone-Anchored Hearing Aid Patients (Table 7). number of implants integrated. Canada) in others. The nasal and other sites had too few implants placed to draw any conclusions. Of the 48 implants placed. mastoid. Twenty-eight implants were placed into 6 orbital operative sites with 1 early fixture loss. The 7 patients received a total of 36 implants in 8 operative sites. Göteborg.4% . The respondents and the centers identified are provided in Table 4. Ontario. All of the 7 patients reported had received a dosage of 4. producing an overall success rate of 94.9%. With the implants used to retain bone-anchored hearing aids. Mississauga.JOMI on CD-ROM. Implants placed outside these regions were grouped under a separate but collective category. all were of the Brånemark 3. Sweden). This information was requested for the orbital. and nasal regions. The only criterion for success applied in the present study is that at the time of data gathering the implant was considered integrated. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… contacted. Results Of eight centers contacted. Twenty-four of the implants were of the Xomed Audiant type and the remaining 24 were of the Brånemark extraoral type. the implants were found to be of the Brånemark type in some cases and of the Xomed Audiant type (Xomed-Surgitek. six responded as having placed extraoral implants. All of the 138 fixtures placed were of the Brånemark type and of these 2 were lost early and 1 late.6%) than the mastoid region (98. The orbit produced a slightly lower success rate (96.8% overall individual implant success rate.0%. and number of implants lost late (more than 1 year after placement). 2 implants were lost early. Nonradiated Patients (Table 5). but the number of implants placed in this region is too low to draw any conclusions. Each center was asked to supply information in the form reported by Parel and Tjellström11 and to indicate the date of initiation of extraoral implant services to patients. It was found that the Canadian experience with craniofacial osseointegration varies between 12 and 48 months (Table 4).4%. The success rate in the orbit was 96. Implants placed into the mastoid region to retain bone anchored-hearing aids (BAHA) had been used in 46 patients. Placement of fixtures into the mastoid region to retain a BAHA produced an overall individual implant success rate of 97. Radiated Patients (Table 6). which was markedly lower than the mastoid and orbital regions. number of implants lost early (less than 1 year after placement). 1 fixture was lost early. In the case of implants used to retain facial prostheses.000 rads and 3 had been treated with hyperbaric oxygen. yielding a 97.9%). The nasal region had a success rate of 80.00-mm extraoral fixture type (Nobelpharma AB.

providing an overall success rate of 97. number of patients treated. The total Canadian experience involved the placement of 222 extraoral implants in 91 patients. Swedish. Consequently. In the case of the intraoral experience with osseointegrated implants. Of the 222 implants placed. In this patient group. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… Total Canadian Experience (Table 8). 1. thereby providing an individual implant success rate of 97.1%.3%. As the international experience with this treatment modality progresses. providing an overall success rate of 95. and United States' Experience The combined results show that the treatment of 603 nonradiated patients has been reported (Table 9).190 have been regarded as stable at the time of reporting. and this declines respectively in the United States and then Sweden. for a success rate of 69. 198 were of the Brånemark extraoral type and the remainder were of the Xomed Audiant variety. and distribution of case type treated. In the radiated group of patients.5%. with 34 patients being reported. 1. Of the 6 implants that failed to integrate. As each of these factors increases. and United States' experience indicated that 637 patients have had 1. there are many variables not addressed in the data presented. Swedish. Combined Result of Canadian.290 implants reported as integrated. The total combined Canadian.266 were of the Brånemark type and 24 were of the Xomed Audiant type. Of importance is that the experience in all three countries provides similar rates of individual implant success. the success rate is highest in Canada.4% . 5 were lost early (less than 1 year after insertion) and 1 was a late loss (more than 1 year after insertion). with intracenter. In this context. however. The data presented have been collected retrospectively and the only criterion for success is that at the time of data gathering the implant was considered integrated. The results do. A much smaller group of radiated patients has been treated. national.JOMI on CD-ROM. the results presented in the current study should be seen only as showing trends. These difference are thought to be a function of time of follow-up. In this group. it is important that treatment outcomes be documented and reported.365 extraoral implants placed and that 1. It is in this direction that future reporting of extraoral implant treatment outcome reporting should progress. it appears that the success rate can be expected to decline toward an as yet unestablished baseline for radiated patients. Discussion Craniofacial osseointegrated implants offer patients who wear facial prostheses a significantly improved quality of life.221 extraoral implants have been placed and 1.290 implants have integrated. Of the 1. A total of 216 implants was considered to have integrated. . and international prospective studies becoming the norm. 144 implants were placed and 100 of these have successfully integrated. provide important information on potential trends of individual implant success rates. the level of documentation of treatment outcome has continued to evolve.

so that with time there may be a shift in the expected individual implant success rate in the orbit. Canada 97. with rates above 98% in all three countries. and serious comment cannot be made at this time. The placement of fixtures in radiated tissue provides an important avenue for future research.9%). In nonradiated patients (Tables 1 and 5). whereas the Swedish result was 91. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… potential for replication of results. This difference is likely attributable to the longer period of follow-up in the Swedish group. In the radiated patient group. the benefits of convenience alone in being able to wear a bone-anchored hearing aid add substantially to quality of life for these individuals. the Canadian success rate (94. In the mastoid region. The influence of hyperbaric oxygen (HBO) therapy remains uncertain but promising at this time. As was suggested previously. hence valid comment is not possible. For patients who require a bone-conduction hearing aid. very few implants have been placed into the nasal region.8%.6%) were very similar. preoperative and postoperative HBO has been administered to radiated patients in Göteborg. The number of patients is considered too few and the follow-up period too short to report on 13 . nasal. Even at this early juncture.4 ATA (atmosphere absolute pressure) for 90 minutes once a day for 20 days preoperatively and 10 days postoperatively. United States 79. it is evident that even in the nonradiated patient important variability exists in the expected regional success rates. the individual implant success rate is' remarkably uniform. For the past 3 years.5%). the success rates for orbits in the United States (96. While the overall nonradiated patient group result indicates an expected success rate of 97. The clinician should be well aware of these when considering treatment with extraoral implants.5%. The success rates achieved in Sweden and Canada with placement of implants in the mastoid region for retention of bone-anchored hearing aids indicates that this procedure carries a very high rate of predictability (Sweden 99.7%. and indications of directions for future research. There is little reason to believe that the success rate in Canada for radiated orbits will not sharply decline as the number of patients increases and the duration of follow-up is extended. Parel and Tjellström11 discussed the reported disparity in success of implants in the nasal region (Sweden 100%. There will undoubtedly be changes in the success rates for the different osseous regions with time. A modified Marx protocol12 has been used by administering 2.3%) and Canada (96. They attributed the difference to the United States' sample being larger and perhaps the Swedish group having more experience with epithelial penetration factors. this difference is thought to be a function of duration of follow-up and number of patients treated.JOMI on CD-ROM. other) is scant. The international experience for treatment in other regions (mastoid. In the Canadian experience. the mastoid region appears to elicit predictable success rates with the use of osseointegrated implants. The total experience in the orbit is still relatively small in relation to the mastoid region experience.4%) was found to be far higher than either the Swedish or United States' results.

Individual implant assessment provides little insight into patients' response to treatment. then it may be important not to expect osseous tissues of varying anatomic locations in the craniofacial skeleton to provide similar success rates. The . Clinicians contemplating extraoral implant placement in radiated patients might heed the words of caution issued by Parel and Tjellström. Likewise. 1992). The available data suggest expected baseline individual implant success rates for the mastoid region in nonradiated patients. If this is so. the biologic and mechanical milieu is very different. There are challenges ahead to determine objective means of extraoral implant assessment. personal communication. this may not be important to a patient with an orbital defect who has had six implants placed. and the length of the implants is far shorter than that of the intraoral implants. they cannot be routinely radiographed at the present time. there could be a problem of continuity of concept from the oral experience. available data for radiated patients do not provide an expectation of baseline success rates.11 They considered the overall success rate in radiated patients to be disappointingly low. Extraoral implants can only be evaluated by assessing implant immobility and the periabutment skin reaction.JOMI on CD-ROM. While these rates are lower than those desired. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… formally. Related to the issue of success rate interpretation of individual implants is the matter of what constitutes success. The loads applied to extraoral implants are different and the connection through the skin to the external environment provides a totally different soft tissue environment for the abutment. but the preliminary results are considered promising13 (Granström G. Conversely. These lower rates of success should perhaps not currently be viewed as failure. It may be disturbing to the clinician who routinely achieves 98% individual success rates with intraoral implants to have to accept 50% success rates in the orbit. However. Intraoral implants are connected through the oral mucosa. It may not be wise to apply continuity of concept from the oral to the extraoral experience. which is bathed in saliva providing a tenacious protective environment for the soft tissue-abutment interface. but rather as attainable success rates for the present. Only the mandible and maxilla are involved in the oral experience and these osseous foundations have been the subject of intense scrutiny. so that understanding of their biologic and mechanical behavior is enhanced. Conclusion Craniofacial osseointegration provides a significant means of improving the quality of life for patients who wear facial prostheses and bone-anchored hearing aids. osseointegration rates in the presence of adjunctive therapies might become acceptable at lower rates of integration. three of which have survived and adequately support an orbital prosthesis There is a need with craniofacial implants to develop success criteria that provide a wider view of what constitutes successful treatment outcome. In the case of extraoral implants. The osseous encasement of the extraoral implant varies greatly between regions.

and other regions of the craniofacial complex in radiated and nonradiated patients. . particularly in radiated patients.JOMI on CD-ROM. so the individual implant success rates will change. These criteria should take into account the uniqueness of extraoral osseointegration and its distinctiveness from the intraoral experience. Clinicians considering use of extraoral implants in the radiated patient should do so with the greatest care and within a clinical environment familiar with care of this category of patient. mastoid. There is a need for research into factors influencing many of the biologic and mechanical aspects of extraoral osseointegration. The results presented should be interpreted as trends only because it is evident that as the number of implants assessed continues to grow and the duration of assessment increases. The mastoid and orbital regions provide a high degree of predictability with regard to extraoral implant usage. nasal. Attention must be given to prospective studies to evaluate treatment outcome with extraoral implants. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… international multicenter data presented indicate trends in expected success rates for orbital. The use of extraoral implants in the midface and in all regions of radiated patients provides results of increased variability. Criteria for evaluation should be defined for extraoral osseointegration.

Br J Oral Surg 1966. The United States and Swedish experience with osseointegration and facial prostheses. Southampton: Millbrook Press. Johannesburg: University of Witwatersrand. South Africa: University of Witwatersrand.55:600-606. 6. Assessment of the mechanical properties of some facial prosthetic adhesives: A preliminary report. Kline SN. Southampton: Millbrook Press. Retention of prostheses. 3. Sandlewick JW. 1984.43:552-560.4:157-182. Hulland CV. Int J Oral Maxillofac Implants 1992. Standish SM (eds). 9. J Am Dent Assoc 1985.6:75-79. Johannesburg. Int J Oral Maxillofac Implants 1991. Part II: extraoral applications. In: Chalian VA. Bogan RL. Tjellström A. Parel SM. Maxillofacial Prosthetics: Multidisciplinary Practise. Tjellström A. 1983:402-409.43:426-432. 1970:113-187. The Need for and Value of a Maxillofacial Prosthodontic Service in the Witwatersrand-Vaal Area [thesis].JOMI on CD-ROM. Marx RE. 1983:410-419. 10. 7. Rahn AO. Prevention of osteoradionecrosis: A randomized prospective clinical trial of hyperbaric oxygen versus penicillin. Granström G. Adhesion to skin— principles and applications. Facial reconstruction by prosthetic means. Brånemark P-I. ed 1. Jacobsson M. 8. 4. Osseointegration in maxillofacial prosthetics. Proceedings of the International Congress on Maxillofacial Prosthetics and Technology. 1972: ch 8. Maxillofacial Prosthetics—Principles and Concepts. Castleberry DJ. Roberts AC. 1987. 5. Proceedings of the International Congress on Maxillofacial Prosthetics and Technology. The Bond Strength of Facial Prosthetic Adhesive Systems [thesis]. J Prosthet Dent 1986. In: Conroy BF. Diminishing dependence on adhesives for retention of facial prostheses. 11. Hulland SM. In: Conroy BF. Russouw C. Drane JB. Boucher LJ. Turner TD. Parel SM. Lewis DH. Tjellström A. Parel SM. J Prosthet Dent 1980. . Philadelphia: Saunders.111:49-54. Chalian A. 2. Bonner E. Baltimore: Williams and Wilkins. An assessment of recent advances in external maxillofacial materials. J Prosthet Dent 1980. Gion G. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… 1. Page K. Titanium implants in irradiated tissue: Benefits from hyperbaric oxygen. Johnson RP. 12.7:15-25. 13.

1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… .JOMI on CD-ROM.

1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… .JOMI on CD-ROM.

1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… .JOMI on CD-ROM.

JOMI on CD-ROM. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… .

1 This 32-year-old patient has right-sided hemifacial microsomia and an associated microtia. 2 Bar connects three implants. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… Fig. Note the apparent downward and forward movement of the reconstructed ear. which have been placed into the mastoid region to support an auricular prosthesis . .JOMI on CD-ROM. Fig. The patient had undergone numerous surgical revisions over the years and was dissatisfied with the result.

4 Extraoral implant-retained auricular prosthesis in position on the patient. 3 This view of the fitting surface of the silicone prosthesis shows that the resin substructure houses the retentive clips. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… Fig. Fig.JOMI on CD-ROM. .

6 Abutment for a bone-anchored hearing aid penetrates the skin behind the ear. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… Fig. .JOMI on CD-ROM. Note the skin graft placed around the abutment to ensure a nonmobile and hairless zone around the abutment. Note the plastic insert for connecting the hearing aid. 5 Abutment for a bone-anchored hearing aid connected through the skin behind the ear. Fig.

7 Bone-anchored hearing aid connected to the abutment. 1993 Feb (197-204 ): Craniofacial Osseointegration: The Canadian E… Copyrights © 1997 Quinte… Fig. .JOMI on CD-ROM.